Mr. Lynam to Oversee Clinical Studies of Sigyn Therapy™ to Treat Life-Threatening Inflammatory Conditions
SAN DIEGO, Jan. 26, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Sigyn Therapeutics, Inc. (OTCMarkets: SIGY), a medical technology company focused on the treatment of life-threatening inflammatory conditions precipitated by Cytokine Storm Syndrome (the Cytokine Storm), announces the appointment of Eric Lynam as Head of Clinical Affairs. Lynam, who has played key roles in developing, contracting and conducting over 190 clinical trials, will oversee clinical studies of Sigyn Therapy™ in the United States and abroad. Previously, Mr. Lynam was the Director of Scientific and Medical Affairs for Pharmatech Incorporated until its recent acquisition by Caris Life Sciences. While at Pharmatech, Mr. Lynam pioneered a high efficiency, patient centered clinical trials system, providing on-demand trial access to a network of more than 1,500 investigators.
Sigyn Therapy is a novel blood purification technology designed to overcome the limitations of previous drug and device candidates to treat sepsis and other life-threatening inflammatory disorders. To support the advancement of Sigyn Therapy, the Company plans to submit an Investigational Device Exemption (IDE) to the United States Food and Drug Administration (FDA) during the course of 2021. In a related endeavor, Mr. Lynam contributed to an IDE submission that resulted in FDA approval to initiate human studies of a first-in-industry blood purification technology to treat life-threatening viral infections. Subsequently, Mr. Lynam provided on-site clinical services that contributed to the successful completion of the IDE approved study.
Cytokine Storm Syndrome is an excessive response of the immune system that can be induced by infectious and non-infectious conditions. A hallmark indicator of Cytokine Storm Syndrome is the excessive or uncontrolled release of pro-inflammatory cytokines into the bloodstream, which can lead to organ failure and cause death. The annual market opportunity to address Cytokine Storm related indications exceeds $20 billion and includes sepsis, the most common cause of in-hospital deaths worldwide. Virus-induced Cytokine Storm Syndrome is a leading cause of death resulting from severe SARS-CoV-2 (COVID-19) infections.
Incorporated within Sigyn Therapy is a cocktail of adsorbent components with unique binding and capture characteristics to optimize the broad-spectrum depletion of inflammatory targets from the bloodstream. These targets include pro-inflammatory cytokines, endotoxin and CytoVesicles (extracellular vesicles that transport inflammatory cytokine cargos) that participate in concert with freely circulating cytokines to further escalate the Cytokine Storm. CytoVesicles are an important yet previously elusive target as they can be 20-60 times larger than cytokines themselves.
About Sigyn Therapeutics
Sigyn Therapeutics™ is a development-stage therapeutic technology company headquartered in San Diego, California USA. Our focus is directed toward a significant unmet need in global health; the treatment of life-threatening inflammatory conditions that are precipitated by Cytokine Storm Syndrome and not addressed with an approved therapy. Our mission is to save lives.
Sigyn Therapy™ is a novel blood purification technology designed to mitigate cytokine storm syndrome through the broad-spectrum depletion of inflammatory targets from the bloodstream. Cytokine storm syndrome is the hallmark of sepsis, which is the most common cause of in-hospital deaths and claims more lives each year than all forms of cancer combined. Virus induced cytokine storm (VICS) is associated with high mortality and is a leading cause of SARS-CoV-2 (COVID-19) deaths. Other therapeutic opportunities include, but are not limited to bacteria induced cytokine storm (BICS), acute respiratory distress syndrome (ARDS) and acute forms of liver failure, such as hepatic encephalopathy.
To learn more, visit www.SigynTherapeutics.com or www.SigynTherapy.com
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of Sigyn Therapeutics, Inc. (“Sigyn”) that involve substantial risks and uncertainties. All statements contained in this press release are forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words “could,” “will,” “plan,” “intend,” “anticipate,” “approximate,” “expect,” “potential,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about Sigyn’s future financial performance, the impact of management changes, any proposed organizational restructuring, results of operations, capital resources to fund operations; statements about Sigyn’s expectations regarding the capitalization, resources and ownership structure of the combined company; statements about the potential benefits of the transaction; the expected completion and timing of the transaction and other information relating to the transaction; and any other statements other than statements of historical fact. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that Sigyn makes due to a number of important factors, including (i) the risk that the transaction may not be completed in a timely manner or at all, which may adversely affect Sigyn’s business and the price of the common stock of Sigyn, (ii) the failure to satisfy of the conditions to the consummation of the transaction, (iii) the occurrence of any event, change or other circumstance that could give rise to the termination of the merger agreement, (iv) risks related to the ability to realize the anticipated benefits of the transaction, including the risk that the businesses will not be integrated successfully, (v) the effect of the announcement or pendency of the transaction on Sigyn’s business relationships, operating results and business generally, (vi) risks that the proposed transaction disrupts current plans and operations, (vii) risks related to the combined entity’s ability to up-list to a national securities exchange, (viii) risks related to the combined entity’s access to existing capital and fundraising prospects to fund its ongoing operations, (ix) risks related to diverting management’s attention from Sigyn’s ongoing business operations, (x) other business effects, including the effects of industry, market, economic, political or regulatory conditions, future exchange and interest rates, and changes in tax and other laws, regulations, rates and policies, and (xi) risks related to an inability to manufacture Sigyn Therapy, risks related to the clinical advancement of Sigyn Therapy with regulatory agencies, and no assurance that Sigyn Therapy will be proven to be a safe and efficacious treatment for any condition. The forward-looking statements in this press release represent Sigyn’s views as of the date of this press release. Sigyn anticipates that subsequent events and developments may cause its views to change. However, while it may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing Sigyn’s views as of any date subsequent to the date of this press release.
Contact Sigyn Therapeutics, Inc.
Jim Joyce
Chairman, CEO
(619) 368-2000
jj@sigyntherapeutics.com